Erythema MultiformePhase 3SEMCORTICONCT06266221
Severe Erythema Multiforme - CORTICO
A Phase 3 study testing Prednisone 20 Mg and Methylprednisolone 120 Mg in people with Erythema Multiforme, run by Assistance Publique - Hôpitaux de Paris.
Trial summary
Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Erythema Multiforme
- What is being tested?
- Prednisone 20 Mg and Methylprednisolone 120 Mg
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 1 Nov 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 15 years old and 30 kg ≤ Weight ≤ 150 kg
- Clinical diagnosis of severe EM defined as:
- Typical skin lesions if first flare of EM: raised target lesions with 2 or 3 concentric rings located on the extremities or disseminated. In case of recurrent EM, with proven anterior flare (known clinical diagnosis as-sociating typical skin lesions and MM involvement in a previous flare), typical skin lesions are not essential for inclusion, because EM may manifest as isolated mucosal involvement.
- Two or more MMs affected (mouth, throat, eyes, ear, nose, genital and/or anal areas), or only the oral MM affected, if severely affected (score* 2 or 3 of Harman criteria22) with altered general conditions and significant impact on food intake (solid food impossible)
- First flare of EM or acute recurrence of previously diagnosed EM
- Disease flare that has lasted for up to 5 days (≤5 days)
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- Affiliated to a social security scheme
- Able to provide written informed consent; consent of both parents will be col-lected for minors
- score: 1, minor activity (up to three erosions); 2, moderate activity (more than three but less than 10 erosions, or generalized desquamative gingivitis); 3, severe (more than 10 discrete erosions or extensive, confluent erosions, or generalized desquamative gingivi-tis with discrete erosions at other oral sites).
Who cannot join
- EM without involvement of oral cavity compromising normal solid food
- Patients unable to eat solid food outside of their current pathology (erythema multiforme)
- Other diagnosis potentially involving MMs: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), pemphigus, herpetic gingivostomatitis
- Systemic Corticosteroids prescribed for another disease on inclusion day (any dose)
- Use of systemic Corticosteroids for > 5 days for any previous flare of EM (>10mg),
- Contraindication to systemic Corticosteroids:
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- hypersensitivity to systemic Corticosteroids or to an excipient;
- uncontrolled primary bacterial, viral, fungal or parasitic infection
- psychotic states not yet controlled by treatment
- Sepsis (shock, cyanosis, hypothermia, low blood pressure monitored succes-sively twice (systemic blood pressure < 90 mmHg and diastolic blood pres-sure < 60 mmHg)
- Kidney or liver insufficiency (creatinine level ≥ 150 µmol/L; aspartate ami-notransferase or alanine aminotransferase level > 3 times the upper limit of normal)
- Current cancer with the exception of non-metastatic skin carcinoma not re-quiring immediate medical treatment
- Pregnant or breastfeeding
- Person subject to safeguards of justice
- Person deprived of liberty by judicial or administrative decision
- Person subject to psychiatric care without their consent
- Person admitted to a health or social establishment for purposes other than those of research
- Person unable to express their consent
- Person under legal protection (guardianship or curatorship)
- Participation in another interventional study involving human participants or in the exclusion period at the end of a previous study involving human partici-pants, if applicable
- On state medical aid
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Olivier Chosidow, PhD contact
About this study
Official title: Severe Erythema Multiforme: A Randomized Controlled Trial Comparing a Short Systemic Corticosteroids Regimen to Placebo in the Acute Established Phase
Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.
The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.
Read more
This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.
A stratification according to the food intake classification (0,1,2 vs 3) will be performed.
An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue.
- Conditions
- Erythema Multiforme
- Being tested
- Prednisone 20 Mg, Oral Placebo, Methylprednisolone 120 Mg, IV Placebo
- Keywords
- Erythema, Corticoids, Prednisone, Methylprednisolone
- Medical subject headings
- Erythema Multiforme, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone 20 MgDrug
Also called Oral corticosteriods
Oral corticosteriods
Oral PlaceboDrug
Also called placebo
Oral placebo
Methylprednisolone 120 MgDrug
Also called IV corticosteriods
IV corticosteriods
IV PlaceboDrug
Also called placebo
IV placebo
| Study group | Role | What they receive |
|---|---|---|
| Systemic Corticosteroids | Experimental | Oral prednisone at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days.
If the oral route is not possible, IV methylprednisolone will be used at 0.8 mg/kg/day for 3 days, ta-pered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days (equivalent predni-sone dosage).
In the event of a change of route administration (IV then Oral or Oral then IV), the posology of prednisone or methylprednisolone or placebo will correspond to the dosage equivalent to that prescribed at the time of the switch. Receives: Drug: Prednisone 20 Mg; Drug: Methylprednisolone 120 Mg |
| Placebo | Placebo comparator | Oral or IV placebo with the same decrease of dose: same number of tablets for prednisone placebo and same volume as methylprednisolone for its placebo Receives: Drug: Oral Placebo; Drug: IV Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to success
It will be defined by controlled pain (Numeric Rating Scale (NR, range 0-10) score <4 and sustained no need for any level III analgesics, during 48 hours), resumption of non-blended food intake and no need for rescue therapy (IV methylprednisolone at 1mg/kg/day with discontinuation of the current treatment in both arms).
Measured: Day0 to Month1
Evaluation of Pain
It will be evaluated daily by using the NR (0-10), 3 times a day during hospitalization and once a day (worst score of the day) after the hospitalization by phone until achievement of the primary end-point. To avoid confounding bias, management of pain will be standardized: Level I, II and III analgesics will be permitted during the treatment, but analgesics taken will be reported and the success is defined as no need for any level III analgesics.
Measured: Day0 to Month1
Food intake
It will be evaluated qualitatively daily by the investigator team (eg. investigator or collaborator, dietician, trained clinical study technician) by use of a standardized questionnaire. Food intake will be classified as the following categories: 0, impossible to eat; 1, liquid food possible; 2, mixed food possible; 3, chopped food possible; 4, solid food possible. For patient with categories 0, 1 or 2 at baseline, the success will be defined by the resump-tion of categories 3 or 4. For patients with category 3 at baseline, the success will be catego-ry 4.
A subgroup analysis will be performed considering the two food intake classification strata.
Measured: Day0 to Month1
Rescue therapy intake
The rescue therapy will be standardized for all patients in failure of the initial strategy and will be:
IV methylprednisolone at 1 mg/kg/day with discontinuation of the current treatment in both arms.
Measured: From Day 0 until discharge from hospital, assessed up to Day 15
Secondary outcomes (10)
Time to clear or almost clear healing of all sites
"clear" is defined as no erosion or skin ulceration and absence of new lesions and "almost clear" is defined as "presence of 1, or 2 maximum, micro erosions / punctiform millimetric erosions, and absence of new lesions". Healing will be evaluated by the clinician. To avoid bias, the investigators will be trained before the start of the study allowing a standardization of the evaluation of healing
Measured: Day15 and Month1
Time to fever resolution
fever resolution defined as absence of fever (temperature ≤ 37,8°C) for at least 24 h
Measured: From Day 0 until discharge from hospital, assessed up to Day 15
Length of hospital stay
Measured: From Day 0 until discharge from hospital, assessed up to Day 15
Number of days of consumption of level III analgesics
at least once in the day
Measured: From Day 0 until complete healing, assessed up to Month 1
Evaluation of pain
It will be assessed three times a day during hospitalization and once a day (worst score of the day) after the hospitalization until achievement of the primary endpoint.
Measured: From Day 0 until complete healing, assessed up to Month 1
Chopped or solid food intake resumption
Measured: From Day 0 until complete healing, assessed up to Month
Rate of patients in the two groups with need for a rescue therapy
The rescue therapy will be standardized for all patients in failure of the initial strategy and will be:
IV methylprednisolone at 1 mg/kg/day with discontinuation of the current treatment in both arms.
Measured: From Day 0 until discharge from hospital, assessed up to Day 15
Rate of sequelae
cutaneous and mucosal sequelae (ocular, ENT, esophageal, pulmonary and genital sequelae)), assessed clinically at month 3 (M3, if realized) and month 6 (M6)
Measured: Month3 and Month6
Rate of adverse events during the treatment and follow-up
Measured: Day0 to Month6
Evaluation of the quality of life
It will be performed with the use of Patient Global Impression of Change (PGIC), scale on 7 points
Measured: at the end of hospitalization, Day7, Day15 and Month1 and in case of relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erythema MultiformeStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Candy Estevez, M.Sc, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266221
- Sponsor's protocol ID
- APHP200073
- Other IDs
- 2022-000712-59
- Acronym
- SEMCORTICO
- Status last verified
- Feb 2024
- First submitted
- 11 May 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Severe Erythema Multiforme: A Randomized Controlled Trial Comparing a Short Systemic Corticosteroids Regimen to Placebo in the Acute Established Phase
- ClinicalTrials.gov ID
- NCT06266221
- Acronym / sponsor ID
- SEMCORTICO / APHP200073
- Conditions
- Erythema Multiforme
- Keywords
- Erythema, Corticoids, Prednisone, Methylprednisolone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Erythema multiforme (EM) is an acute and often recurrent mucocutaneous disease. EM is considered a hypersensitivity immune-mediated reaction. The two main known triggering factors are Herpes simplex virus (HSV) and Mycoplasma pneumoniae (MP) infections. Typical target skin lesions characterize EM, especially oral MMs. EM is in fact mainly linked to the oral MM involvement, including intense mucosal pain, impaired food intake, weight loss, hospitalization and potential risk of fibrotic sequelae (oral, ocular, genital, oesophageal, respiratory tract) and recurrences.
The objectives of treatment for severe EM in the acute phase are to reduce the duration of lesions, prevent complications and mucosal sequelae. However, despite the lack of evidence and consensus some medical teams often use a short regimen of SCS hoping to obtain a quicker improvement of the condition. However, the use of SCS at the acute phase is not codified and remains debated according to the existent literature. Current studies are mostly retrospective and based on small cohorts or case reports. A randomized, controlled trial would be therefore essential to properly evaluate the benefit of SCS in this pathology and provide strong support to clinicians in their decision making in severe EM during the acute phase.
This research will be a Phase III randomized, multicentric, double-blind, controlled trial with two parallel groups. The efficacy of prednisone, oral at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days is compared to that of placebo, oral for 12 days or IV methylprednisolone if oral route is impossible because of the self-reported inability for the patient to swallow due to the impacts of the oral lesions, with dosage equivalence at 0.8 mg/kg/day for 3 days, tapered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days, then stopped, compared to that of placebo.
A stratification according to the food intake classification (0,1,2 vs 3) will be performed.
An interim analysis is planned after the inclusion of 50 patients. Results of the interim analysis will be presented to the DSMB. During the interim analysis, inclusions may continue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Systemic Corticosteroids | Experimental | Drug: Prednisone 20 Mg, Drug: Methylprednisolone 120 MgOral prednisone at 1 mg/kg/day for 3 days, tapered to 0.75 mg/kg/day for 3 days, 0.50 mg/kg/day for 3 days, 0.25 mg/kg/day for 3 days. If the oral route is not possible, IV methylprednisolone will be used at 0.8 mg/kg/day for 3 days, ta-pered to 0.6 mg/kg/day for 3 days, 0.4 mg/kg/day for 3 days, 0.2 mg/kg/day for 3 days (equivalent predni-sone dosage). In the event of a change of route administration (IV then Oral or Oral then IV), the posology of prednisone or methylprednisolone or placebo will correspond to the dosage equivalent to that prescribed at the time of the switch. |
| Placebo | Placebo comparator | Drug: Oral Placebo, Drug: IV PlaceboOral or IV placebo with the same decrease of dose: same number of tablets for prednisone placebo and same volume as methylprednisolone for its placebo |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 15 years old and 30 kg ≤ Weight ≤ 150 kg
- Clinical diagnosis of severe EM defined as:
- First flare of EM or acute recurrence of previously diagnosed EM
- Disease flare that has lasted for up to 5 days (≤5 days)
- Affiliated to a social security scheme
Key exclusion criteria (21 listed)
- EM without involvement of oral cavity compromising normal solid food
- Patients unable to eat solid food outside of their current pathology (erythema multiforme)
- Other diagnosis potentially involving MMs: Stevens-Johnson syndrome and toxic epidermal necrolysis (SJS/TEN), pemphigus, herpetic gingivostomatitis
- Systemic Corticosteroids prescribed for another disease on inclusion day (any dose)
- Use of systemic Corticosteroids for > 5 days for any previous flare of EM (>10mg),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone 20 MgAlso: Oral corticosteriodsOral corticosteriods | Drug | Systemic Corticosteroids |
| Oral PlaceboAlso: placeboOral placebo | Drug | Placebo |
| Methylprednisolone 120 MgAlso: IV corticosteriodsIV corticosteriods | Drug | Systemic Corticosteroids |
| IV PlaceboAlso: placeboIV placebo | Drug | Placebo |
Primary outcome
Time to success
Time frame: Day0 to Month1
It will be defined by controlled pain (Numeric Rating Scale (NR, range 0-10) score <4 and sustained no need for any level III analgesics, during 48 hours), resumption of non-blended food intake and no need for rescue therapy (IV methylprednisolone at 1mg/kg/day with discontinuation of the current treatment in both arms).
Evaluation of Pain
Time frame: Day0 to Month1
It will be evaluated daily by using the NR (0-10), 3 times a day during hospitalization and once a day (worst score of the day) after the hospitalization by phone until achievement of the primary end-point. To avoid confounding bias, management of pain will be standardized: Level I, II and III analgesics will be permitted during the treatment, but analgesics taken will be reported and the success is defined as no need for any level III analgesics.
Food intake
Time frame: Day0 to Month1
It will be evaluated qualitatively daily by the investigator team (eg. investigator or collaborator, dietician, trained clinical study technician) by use of a standardized questionnaire. Food intake will be classified as the following categories: 0, impossible to eat; 1, liquid food possible; 2, mixed food possible; 3, chopped food possible; 4, solid food possible. For patient with categories 0, 1 or 2 at baseline, the success will be defined by the resump-tion of categories 3 or 4. For patients with category 3 at baseline, the success will be catego-ry 4. A subgroup analysis will be performed considering the two food intake classification strata.
Rescue therapy intake
Time frame: From Day 0 until discharge from hospital, assessed up to Day 15
The rescue therapy will be standardized for all patients in failure of the initial strategy and will be: IV methylprednisolone at 1 mg/kg/day with discontinuation of the current treatment in both arms.
10 secondary outcomes
Time to clear or almost clear healing of all sites
Time frame: Day15 and Month1
Time to fever resolution
Time frame: From Day 0 until discharge from hospital, assessed up to Day 15
Length of hospital stay
Time frame: From Day 0 until discharge from hospital, assessed up to Day 15
Number of days of consumption of level III analgesics
Time frame: From Day 0 until complete healing, assessed up to Month 1
Evaluation of pain
Time frame: From Day 0 until complete healing, assessed up to Month 1
Chopped or solid food intake resumption
Time frame: From Day 0 until complete healing, assessed up to Month
Rate of patients in the two groups with need for a rescue therapy
Time frame: From Day 0 until discharge from hospital, assessed up to Day 15
Rate of sequelae
Time frame: Month3 and Month6
Rate of adverse events during the treatment and follow-up
Time frame: Day0 to Month6
Evaluation of the quality of life
Time frame: at the end of hospitalization, Day7, Day15 and Month1 and in case of relapse
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Olivier Chosidow, PhD contact
Candy Estevez, M.Sc study chair
APHP
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prednisone 20 Mg and Methylprednisolone 120 Mg in people with Erythema Multiforme, run by Assistance Publique - Hôpitaux de Paris.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Saskia Oro, PhD (01 49 81 25 01 ext. +33, saskia.oro@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to success (time frame: Day0 to Month1). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.